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临床试验/NCT03291145
NCT03291145已完成不适用

Exploring Mechanisms and Morphology of QT Interval Prolongation - An Inheritable as Well as an Inducible Phenomenon

Herlev and Gentofte Hospital1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年6月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
QTc

研究概览

简要总结

The projects will try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing".

First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.

详细描述

The aim of the projects is to try and optimise the risk stratification for patients with Long QT syndrome by investigating how the exposure of physical and acoustic stress will affect the QT-dynamics and if beta blockers protect against arrhythmias by suppressing this dynamic QT-prolongation. Furthermore, the project will investigate the effects of Spironolactone on the QT-dynamics tested by "Brisk Standing".

First, patients are tested with known arrhythmic triggers and they are then administered thier normal dose of beta blockers. Hereafter, "Brisk Standing" test is performed and the patients are on Spironolactone for seven days. After seven days treatment the "Brisk Standing" is repeated.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Verified Long QT syndrome mutation, subtype 1 or
  • over 18 years of age

排除标准

  • Atrioventricular block,
  • Left bundle branch block,
  • Left ventricular hypertrophy,
  • Pace rhythm,
  • ST-deviations >1 mm),
  • Left ventricular ejection fraction <50 % and significant valvulopathy,
  • Unstable psychiatric disease
  • Unstable cardiovascular disease.

研究组 & 干预措施

Beta Blockers

Experimental

With and without Beta Blockers

干预措施: Beta Blockers (Drug)

Spironolactone

Experimental

With and without Spironolactone

干预措施: Spironolactone (Drug)

结局指标

主要结局

QTc

时间窗: 7 days

Corrected QT

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peter Marstrand

Medical Doctor, Research Fellow

Herlev and Gentofte Hospital

研究点 (1)

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